Manufacturing Specifications. All Clinical Materials and commercial supplies of Product shall be manufactured in accordance with the specifications determined by MacroGenics and all Applicable Laws and Regulations.
Manufacturing Specifications. Licensee shall manufacture all of the Licensee Products that include the Licensed Technology consistent with standards of high quality and design, and Licensee shall exercise its commercially reasonable efforts to consult and cooperate with Licensor at all times in connection with the manufacture of such Licensee Products. In that regard, as early as possible, and in any event prior to the commencement of distribution of each Licensee Product, Licensee shall provide to Licensor pre-distribution versions of each Licensee Product. Licensee agrees that Licensor shall have the right to test and evaluate all Licensee Products which use Licensed Technology to confirm that such Licensee Products conform to the specifications to be developed by Licensee and Licensor pursuant to Section 5.2 hereof. In the event that Licensor determines that any such Licensee Products do not meet such specifications, Licensor shall immediately notify Licensee thereof and Licensee shall use all commercially reasonable efforts to modify such Licensee Products to meet such specifications.
Manufacturing Specifications. The Manufacture of all Xxxxxx Products during the term of this Agreement shall be the responsibility of DURA. DURA shall manufacture, or cause its subcontractor to manufacture, the Xxxxxx Products under this Agreement in compliance in all material respects with all requirements of applicable laws and regulations and all applicable good manufacturing practices, as prescribed from time to time by the FDA and other applicable worldwide regulatory authorities, using the specifications, manufacturing methods and formulae as agreed upon by DURA and Xxxxxx Corp. II in writing.
Manufacturing Specifications. All Study Materials and commercial supplies of Product shall be manufactured in accordance with the specifications (i) determined by MacroGenics, (ii) subject to Section 5.3, consistent with those Territory specific specifications required by the applicable Regulatory Authority in the Territory provided by Zai to MacroGenics in writing, and (iii) in compliance with all regulatory requirements and all Applicable Laws and Regulations, as further set forth in the supply agreements and related quality agreements.
Manufacturing Specifications. All clinical and commercial supplies of Collaboration Molecules and Collaboration Product supplied by MacroGenics shall be manufactured in accordance with the specifications (i) determined by MacroGenics, (ii) subject to Section 8.1(d), consistent with those specifications required by the applicable Regulatory Authority in the Territory provided by Zai to MacroGenics in writing, and (iii) in compliance with all regulatory requirements and all Applicable Laws and Regulations, as further set forth in the supply agreements and related quality agreements.
Manufacturing Specifications. (A) Seller shall manufacture the Cosmetics Products in strict accordance with Buyer's specifications, and such revisions, accepted by Seller, as may be made during the period of this Agreement. The product to be produced shall be merchantable quality.
(B) If Buyer desires to make changes in the Manufacturing Specifications, and/or any of the material or services covered herein during the period of this Agreement, it shall be Buyer's privilege to do so, and any increase or decrease in price shall be only the mutually agreed upon increased or decreased cost of material and/or labor involved in furnishing materials or services under the revised standards and specifications, plus 25% Flat. Seller agrees to make every reasonable effort to comply with Buyer's revised standards and
Manufacturing Specifications. ONCOVIR shall manufacture, or cause to be manufactured, Product under this Agreement in compliance with all applicable Specifications, GENOCEA’s Purchase Order requirements, Regulatory Standards and Regulatory Requirements and in accordance with the representations and warranties set forth in this Agreement.
Manufacturing Specifications. 2.1. CHEMI shall supply the Bupropion Hydrochloride to OREXIGEN in accordance with (a) the specifications set forth on Schedule A attached hereto, and (b) the specifications, methods, processes and procedures, including site of manufacture, set forth in CHEMI’s drug master file (“DMF”) for Bupropion Hydrochloride filed with the U.S. Food and Drug Administration (“FDA”) pursuant to Section 2.3 (both (a) and (b), including any modifications approved in accordance with Section 2.2 collectively, the “Specifications”). If CHEMI wishes to make any change to the Specifications (including, but not limited to, any change that could affect the purity, potency, identity and/or physical properties of the Bupropion Hydrochloride or the site of its manufacture), it shall notify OREXIGEN in writing in advance thereof and comply with the requirements of Section 2.2 prior to implementing such change. Such notification shall describe the proposed change in sufficient detail, so as to permit OREXIGEN to understand the reasons for the proposed change and evaluate the impact of such change on its development plans, its plans to seek regulatory approval and its commercialization plans with respect to oral formulations containing Bupropion Hydrochloride (the “Finished Products”). OREXIGEN may request from time to time that CHEMI implement voluntary changes to the Specifications upon written request to CHEMI. CHEMI shall use commercially reasonably efforts to implement such request from OREXIGEN, which if carried out shall be at OREXIGEN’s expense. In the event that a voluntary change to the Specifications is to be implemented, CHEMI shall perform, at OREXIGEN’s expense, all analytical or experimental work in connection with making any such changes, but OREXIGEN shall be responsible, at its expense, for filing all changes proposed by OREXIGEN in connection with any regulatory approval, and for seeking approval of any such change required by each applicable Regulatory Agency (as defined in Section 2.2).
2.2. Without limiting the generality of the foregoing provisions, CHEMI shall not change the Specifications unless [* * *], each having jurisdiction over Bupropion Hydrochloride, the Finished Products or OREXIGEN’s marketing of Finished Products (each a “Regulatory Agency”). If any change to the Specifications requires the approval of a Regulatory Agency, such change [* * *]. To the extent [* * *]. For the avoidance of doubt, CHEMI shall not supply to OREXIGEN hereunder, and OREXIG...
Manufacturing Specifications. Seller shall manufacture, produce and bulk package for Buyer the nutritional products described on Exhibit A which is attached hereto and incorporated herein (the “Products”). The detailed formulations and specifications for the manufacturing, producing and packaging of the Products are described on Exhibit B attached hereto and incorporated herein (“the Standards”). The parties may, from time to time amend Exhibits A and B to modify or change same by mutual agreement.
Manufacturing Specifications. In the event that Stereotaxis exercises its rights to market and distribute the Daughter Products under Section 4.5, prior to the first delivery to Stereotaxis of Daughter Products, Biosense will provide to Stereotaxis a detailed manufacturing specification (the "DP Manufacturing Specifications") for the Daughter Products. Such DP Manufacturing Specifications will be consistent with the Daughter Product Specifications agreed upon by the Parties, and will be sufficient in all events to ensure that Daughter Products meet all criteria and specifications set forth in the applicable Daughter Product Specifications (including without limitation, performance specifications). At Biosense's direction, such DP Manufacturing Specifications will contain a level of detail necessary to make such products. Stereotaxis will provide similar Manufacturing Specifications to Biosense for the Components prior to Stereotaxis' first shipment of commercial quantities of the Components to Biosense ("Component Manufacturing Specifications"). From and after the delivery of such Manufacturing Specifications, the Daughter Products and Components will mean for all purposes of this Agreement those certain Daughter Products and Components reflected by and defined in the Manufacturing Specifications. Biosense, in the case of the DP Manufacturing Specifications, and Stereotaxis, in the case of the Component Manufacturing Specifications, will have the right to modify and will modify such Manufacturing Specifications from time to time to reflect modifications made by Biosense to the Daughter Products and by Stereotaxis to the Components, and in all cases, one party shall communicate such changes to the other party. Such modifications will in all cases be consistent with all applicable Daughter Product Specifications and Component Specifications. Any modifications not consistent with such specifications will require the unanimous approval of the Joint Steering Committee.
